Europe Recommends RSV Antibody for Infants
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced today it adopted a positive opinion for Beyfortus® (nirsevimab), an investigational long-acting antibody.
Beyfortus is a single-dose passive immunization designed to prevent respiratory syncytial virus (RSV) and lower respiratory tract disease in newborns and infants during their first RSV season.
Beyfortus is being developed jointly by Sanofi and AstraZeneca.
Iskra Reic, EVP, Vaccines and Immune Therapies, AstraZeneca, stated in a press release on September 16, 2022, “This positive CHMP opinion underscores Beyfortus’ potential as a ground-breaking, first-in-class passive immunization that could transform the medical community’s approach to RSV prevention in infants.”
Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid, and direct protection against disease.
The CHMP based its positive opinion on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY, and Phase 2b trials.
In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose.
The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.
RSV is the most common cause of LRTIs and a leading cause of hospitalization in all infants, with most hospitalizations occurring in infants born healthy and at term.
As of September 16, 2022, the U.S. FDA had not approved an RSV prevention vaccine.
Additional RSV vaccine and antibody development news are posted at PrecisionVaccinations.com/RSV.